FORWARD CAD IDE Study

General Inclusion Criteria:

1. Subject is ≥18 years of age

2. Subject is able and willing to comply with all assessments in the study.

3. Subjects with native coronary artery disease including stable angina or followingstabilization after acute coronary syndromes (ACS) for non-emergent percutaneouscoronary intervention (PCI)

4. Biomarkers (troponin) must be:

5. less than or equal to the upper limit of lab normal within 24 hours prior tothe procedure or may be drawn from the side port of the sheath at the time ofindex if the PCI is a non-emergent procedure and has stable angina (result willnot be known prior to procedure); OR

6. if above the upper limit of lab normal, biomarker result must be less than 5times the upper limit of lab normal within 24 hours prior to the procedure andthe following criteria must be met: • The procedure must not be emergent andthe subject cannot have angina at rest.

7. Left ventricular ejection fraction (LVEF) >30% within 6 months (note: in the case ofan event (MI or Revascularization) the LVEF must be taken post-event and in the caseof multiple assessments of LVEF, the measurement closest to enrollment will be usedfor this criterion; may be assessed at time of index procedure).

8. Subject, or legally authorized representative, signs a written Informed Consent formto participate in the study, prior to any study-mandated procedures.

9. Estimated life expectancy >1 year.

10. Lesions in non-target vessels requiring PCI may be treated either:

11. >30 days prior to the study procedure if the procedure was unsuccessful orcomplicated; OR

12. >24 hours prior to the study procedure if the procedure was successful anduncomplicated (defined as a final lesion angiographic diameter stenosis <30%and TIMI 3 flow (visually assessed) for all non-target lesions and vesselswithout perforation, cardiac arrest or need for defibrillation or cardioversionor hypotension/heart failure requiring mechanical or intravenous hemodynamicsupport or intubation, and no evidence of elevated biomarkers post-procedure;OR

13. >30 days after the study procedure Angiographic Inclusion Criteria

14. The target lesion must be a de novo coronary lesion that has not been previouslytreated successfully with any interventional procedure

15. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or oftheir branches)

16. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm

17. The target lesion must meet one of the following criteria:

18. Target lesion stenosis >90% up to 40 mm in length and evidence of moderate orsevere calcification at the lesion site. Moderate calcification defined asangiography with densities noted only during the cardiac cycle prior tocontrast injection; severe calcification defined as angiography withfluoroscopic radio-opacities noted without cardiac motion prior to contrastinjection involving both sides of the arterial wall; OR

19. Chronic total occlusion presenting with J-CTO score of 1 with evidence ofcalcification and occlusion length up to 20 mm.

20. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior toinsertion of Shockwave Javelin Coronary IVL catheter (antegrade wire technique only)

General Exclusion Criteria:

1. Any comorbidity or condition which may prevent compliance with this protocol,including follow-up visits

2. Subject is participating in another research study involving an investigationalagent including pharmaceutical, biologic, or medical device that has not reached theprimary endpoint

3. Subject is pregnant or nursing (a negative pregnancy test is required for women ofchild-bearing potential within 7 days prior to enrollment)

4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines

5. Subject has an allergy to imaging contrast media which cannot be adequatelypre-medicated

6. Subject experienced an acute STEMI within 30 days prior to index procedure

7. New York Heart Association (NYHA) class III or IV heart failure

8. Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73m2 (usinginstitutional formula)

9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any priorintracranial hemorrhage or permanent neurologic deficit

10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months

11. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse bloodtransfusions if one should become necessary

12. Coagulopathy, including but not limited to platelet count <100,000 or InternationalNormalized ratio (INR) >1.7 (INR is only required in subjects who have takenwarfarin within 2 weeks of enrollment)

13. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders

14. Subject has an active systemic infection on the day of the index procedure witheither fever, leukocytosis or requiring intravenous antibiotics

15. Subjects with clinical evidence of cardiogenic shock

16. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)

17. Subjects with an estimated life expectancy of less than 1 year

18. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR,MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure

19. Planned non-coronary interventional or surgical structural heart procedures (e.g.,TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the indexprocedure

20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery

21. Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device,or any investigational device other than coronary IVL Angiographic Exclusion Criteria

22. Unprotected left main diameter stenosis >30%

23. Evidence of a serious angiographic complication in the target vessel prior totreatment with coronary IVL (dissection, perforation, abrupt closure, persistentslow-flow or persistent no reflow)

24. Definite or possible thrombus by angiography in the target vessel

25. Evidence of aneurysm in target vessel within 10 mm of the target lesion

26. Second lesion with >50% stenosis in the same target vessel as the target lesionincluding its side branches

27. Chronic total occlusion of the target lesion, J-CTO ≥2

28. Target lesion is located in a native vessel that can only be reached by goingthrough a saphenous vein or arterial bypass graft

29. Previous stent within 5 mm of the target lesion

30. Failure to successfully cross the guidewire across the target lesion

31. Planned use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), orretrograde dissection and reentry (RDR) crossing technique at any time during theprocedure.